Dynamic exoskeletal orthosis

ABSTRACT

An exoskeletal orthosis includes a proximal cuff including a hinge along an upper edge of the cuff; an ankle section/footplate; and at least one posterior strut connecting the proximal cuff to the ankle section and foot plate.

RELATED APPLICATIONS

This application is a Continuation application of U.S. Ser. No.13/773,776, filed on Feb. 22, 2013, which claims priority of U.S. patentapplication Ser. No. 13/450,539, filed on Apr. 19, 2012, which claimspriority to U.S. Provisional Patent Application Ser. No. 61/518,801,filed on Apr. 20, 2011, the entireties of which are incorporated hereinby reference.

FIELD OF INVENTION

The present invention is directed to an ankle foot orthosis or brace, inparticular to a dynamic exoskeletal orthosis.

BACKGROUND

Orthotics are devices that are made to correct or maintain alignment ofdifferent parts of the body, hence the name “braces.”

An ankle foot orthosis (AFO) supports the joints of the foot, as well asthe ankle. These devices can be used to protect, correct or limit motionat the joints by supporting a person's limb that has suffered from lossof strength or alignment due to disease or trauma. AFOs can be a soliddesign at the ankle with no motion allowed, or with joints to allowcertain degrees of motion.

Historically, bracing options for those with pain/weakness/decreasedrange of motion about the ankle have been severely limited. The mostcommon types of bracing either provided adequate strength compensationin the instance of an isolated peroneal neuropathy or were designed withvery stiff orthotic materials that essentially immobilized the ankle anddid not allow a more normal gait or higher level activities.

SUMMARY OF INVENTION

According to an aspect of the present invention, an exoskeletal orthosiscomprises a proximal cuff comprising a hinge along an upper edge of thecuff; an ankle section/footplate; and at least one posterior strutconnecting the proximal cuff to the ankle section/footplate.

According to another aspect of the present invention an orthosiscomprises a proximal cuff comprising at least one hinge along an upperedge of the cuff; an ankle section/footplate; and at least one posteriorstrut attached at a proximal end to the proximal cuff and attached at adistal end to the ankle section/footplate. The ankle section/footplatecomprises a suprarnalleolar ankle section having a lateral wing and afootplate section extending to the tips of a user's toes and having anarch.

According to another aspect of the invention, a method of treating aninjury is provided comprising fitting an individual having an injurywith an orthosis according to the present invention and placing theindividual's foot with the attached orthosis inside a shoe or boot.

According to yet another aspect of the present invention, an orthosiscomprises a proximal cuff; an ankle section/footplate; and a singleposterior strut connecting a rear of the proximal cuff to a rear of theankle section/footplate.

According to still another aspect of the present invention, a knee anklefoot exoskeletal orthosis comprises a proximal cuff; an anklesection/footplate; dual posterior struts connecting a rear of theproximal cuff to a rear of the ankle section/footplate, and an upperknee orthosis section connected to the proximal cuff and comprising atleast one stretchable band affixed on each side.

According to a further aspect of the present invention, an alignableexoskeletal orthosis comprises a proximal cuff; an anklesection/footplate; and at least one posterior strut connecting a rear ofthe proximal cuff to a rear of the ankle section/footplate. The at leastone posterior strut is fixed onto at least one of the ankle/footplate orthe posterior cuff via a bolt mechanism comprising at least one angledwedge.

According to a further aspect of the present invention, an exoskeletalorthosis comprises a proximal cuff; an ankle section/footplate; and atleast one posterior strut connected to a rear of the proximal cuff viaan upper mounting plate and connected to a rear of the anklesection/footplate via a low mounting plate. The upper and lower mountingplates each have moldable flaps or wings extending from the sidesthereof.

An advantage of the present invention is that the dynamic exoskeletalorthosis allows greater ability to walk and run despite severe lowerextremity physical impairments.

Another advantage of the present invention is that the dynamicexoskeletal orthosis allows for early walking post-injury to high levelactivities with the same orthosis.

Yet another advantage of the present invention is that the dynamicexoskeletal orthosis may be lightweight, durable (tolerates impact ofrunning with a ruck sack, for example, up to about 120 lbs.), and may beused in regular shoes and military boots.

As used herein “substantially”, “relatively”, “generally”, “about”, and“approximately” are relative modifiers intended to indicate permissiblevariation from the characteristic so modified. They are not intended tobe limited to the absolute value or characteristic which it modifies butrather approaching or approximating such a physical or functionalcharacteristic.

In this detailed description, references to “one embodiment”, “anembodiment”, or “in embodiments” mean that the feature being referred tois included in at least one embodiment of the invention. Moreover,separate references to “one embodiment”, “an embodiment”, or“embodiments” do not necessarily refer to the same embodiment; however,neither are such embodiments mutually exclusive, unless so stated, andexcept as will be readily apparent to those skilled in the art. Thus,the invention can include any variety of combinations and/orintegrations of the embodiments described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a dynamic exoskeletal orthosis according to anembodiment of the present invention.

FIG. 2 is a view of a proximal cuff of a dynamic exoskeletal orthosisaccording to an embodiment of the present invention.

FIG. 3 is a view of a dynamic exoskeletal having a dual strutconfiguration according to another embodiment of the present invention.

FIG. 4 is a rear view of a dynamic exoskeletal orthosis showing aposterior strut according to an embodiment of the present invention.

FIG. 5 is a view of a dynamic exoskeletal orthosis attached to aperson's leg and foot.

FIG. 6a is a side view of a partial dynamic exoskeletal orthosisaccording to an embodiment of the present invention.

FIG. 6b is a top view of the partial dynamic exoskeletal orthosis ofFIG. 6 a.

FIG. 7 is a side view of a dynamic exoskeletal orthosis according toanother embodiment of the present invention.

FIG. 8 is a side view of a dynamic knee ankle foot exoskeletal orthosisaccording to an embodiment of the present invention.

FIG. 9 is a rear view of a dynamic knee ankle foot exoskeletal orthosisaccording to an embodiment of the present invention.

FIG. 10 is a side view of a dynamic exoskeletal orthosis according toanother embodiment of the present invention.

FIG. 11 is a rear view of a dynamic exoskeletal orthosis of FIG. 10.

FIG. 12 is a side view of a knee ankle foot exoskeletal orthosisaccording to another embodiment of the present invention.

FIG. 13 is a side rear perspective view of the knee ankle footexoskeletal orthosis according to FIG. 12 in use.

FIG. 14 is a rear view of a knee ankle foot exoskeletal orthosisaccording to FIG. 13 in use.

FIG. 15 is a side view of a knee ankle foot exoskeletal orthosisaccording to FIG. 13 while a user is seated.

FIG. 16a is a side view of a bolt mechanism for an alignableconfiguration of an exoskeletal orthosis according to an embodiment ofthe present invention.

FIG. 16b is a top view of the bolt mechanism of FIG. 16 a.

FIG. 17 shows dual posterior struts and mounting plates for anon-alignable configuration of an exoskeletal orthosis according to anembodiment of the present invention.

Given the following enabling description of the drawings, the methodsand apparatus should become evident to a person of ordinary skill in theart.

DETAILED DESCRIPTION OF INVENTION

The orthosis of the present invention is designed to allow walking andrunning for individuals or patients with severe injury to the lower limbthat causes reduced ankle range of motion, weakness, and pain. Theorthosis allows for a range of activities including, but not limited to,at least one of early ambulation during an early post-injury phase,agility and impact activities, running, sprinting, or deploying with amilitary unit.

The orthosis of the present invention is designed to compensate forweakness, pain, and/or decreased range of motion (either alone or incombination) at the ankle that result from a variety of potentialdiagnoses including, but not limited to, at least one of ankle fusion,talus or calcaneus fractures, tibial nerve injuries, peroneal nerveinjuries, partial foot amputation (which results in ankle plantarflexionweakness), soft tissue loss in the leg (resulting in inherent weakness),or pain in the ankle during weight bearing activities.

Current research suggests that the orthosis of the present invention notonly compensates for weakness, but also generates forces about the anklethat more closely approaches the normal gait than other currentlyavailable orthoses. The article Patzowski et al., Comparative Effect ofOrthosis Design on Functional Performance, J. Bone Joint Surg. Ab.,2012; 94:507-15, is incorporated by reference herein in its entirety.The article Patzowski et al., Can an Ankle-Foot Orthosis Change Heartsand Minds?”, J. Surgical Orthopaedic Advances, 20(1):8-18, 2011, is alsoincorporated by reference herein in its entirety.

In specific embodiments, the orthosis of the present invention may beapplied to the leg below the knee. The orthosis (also referred to as theIntrepid Dynamic Exoskeletal Orthosis or IDEO) may comprise thefollowing components (description from an upper/proximal aspect to alower/distal aspect).

A. Proximal Cuff

With reference now to FIG. 1, the exoskeletal orthosis 100 according tothe present invention comprises a proximal cuff 110. The proximal cuffmay comprise at least one of a carbon material, reinforced carbon fibercomposition, or resin material. The cuff may have a bivalve or amonolithic configuration.

A monolithic, one-piece, solid configuration comprises a solid cuff andis designed for a patient who has a stable size of the upper leg (calfand shin) and does not have limited ankle plantarflexion.

In specific embodiments, the proximal cuff may comprise a two piece orbivalve cuff having a hinge 115 (as shown in FIGS. 2-3) along an upperedge or aspect, thereby allowing the proximal cuff 110 to have a wideropening distally when donning the brace. This configuration may beutilized for patients who are not able to plantarflex the ankle enoughto fit through a monolithic (solid) configuration and also allows forvolume fluctuation of the upper leg. The hinge 115 allows the proximalcuff 110 to open upward due to a proximal fixed axis point (see FIG. 2).

In one or more embodiments, the proximal cuff 100 may have a strap 120to help hold it in place while in use.

B. Posterior Strut

The exoskeletal orthosis 100 comprises at least one posterior strut 130for connecting the proximal cuff 110 to an ankle/footplate section 140.The at least one posterior strut 130 may comprise a single bar (e.g.,FIG. 1) or dual bars (e.g., FIG. 3), which may be bonded together. Theat least one posterior strut may be of any shape for example, a flatbar, a cylindrical or tubular shape, or having a circular orsemi-circular cross section. In one or more embodiments, the at least onposterior strut 130 may have a length of about 5 inches to about 13inches (12.7 cm to 33 cm).

In specific embodiments, the at least one posterior strut 130 maycomprise an alignable dynamic carbon strut, for example, a TRULIFELittig strut or a MEDI CLEVER BONE™ strut. The Littig strut wasoriginally designed for use in the upper portion of hip disarticulationprostheses. The MEDI CLEVER BONE™ strut (bone system) may be designedfor use as a dynamic pylon for transtibial prostheses.

The at least on posterior strut 130 may comprise at least one of acarbon material, reinforced carbon fiber composition, or resin material.In a specific embodiment, the at least one posterior strut may have anAerolon core.

In one or more embodiments, the at least on posterior strut may comprisean SLS material. Selective laser sintering (SLS) is an additivemanufacturing technique that uses a high power laser (for example, acarbon dioxide laser) to fuse small particles of plastic, metal (directmetal laser sintering), ceramic, or glass powders into a mass that has adesired 3-dimensional shape.

C. Mounting Plates

The exoskeletal orthosis 100 may comprise at least one mounting plate,for example, two mounting plates: a first mounting plate 150 forattaching one end of the at least one posterior strut 130 to theproximal cuff and a second mounting plate 160 for attaching an oppositeend of the at least one posterior strut 130 to the anklesection/footplate 140 (as shown in FIGS. 1 and 4). In one or moreembodiments, the at least one mounting plate may comprise an ÖSSUR®posterior mounting plate (designed for transtibial prostheses).

The mounting plates 150, 160 may include a fastener including, but notlimited to, at least one of a screw, bolt, nail, nut, adhesive,combination thereof, or any other effective fastener.

The attachment of the at least one posterior strut 130 to an anklesection/footplate 140 may be slightly more proximal than traditionalorthoses. This helps offset motion within the ankle, which is oftenpainful or severely limited in these patients, to the at least oneposterior strut without compromising comfort.

D. Ankle Section/Footplate

The exoskeletal orthosis 100 comprises an ankle section/footplate 140.The ankle section/footplate comprises a supramalleolar ankle section 170and footplate section 180 (e.g., FIG. 1). The ankle section/footplate140 may be a single piece comprising a reinforced carbon fibercomposition. In one or more embodiments, the ankle section 170 comprisesa lateral wing 190 for mediolateral stability and for fitting better inshoes or boots (FIG. 5). In one or more embodiments, the ankle sectionmay also have a medial wing.

In one or more embodiments, the footplate section 180 has a “rollover”shape (e.g., FIG. 1 and FIG. 3). The shape of the footplate section 180positions an individual's toes in slight extension and extends to his orher toetips. A forefoot (end of the footplate) is set in slightplantarflexion compared to a midfoot. In one or more embodiments, theankle section/footplate 140 may be stiff due to the layering ofmaterials and carbon fiber. The footplate section 180 may have an arch(instead of being completely flat) and have extension at themetatarsophalangeal joints, which enables the metatarsal heads to remainin contact with the ground for a longer duration during ambulation.

The plantar surface of the footplate allows optimal function of the atleast one posterior strut and long-term durability of the orthosis. Asnoted, the footplate section may have a gradual roller shape that beginsjust distal to a heel, which may have a cushion. In one or moreembodiment, a portion of the heel, for example a posterior heel base,may comprise a SACH heel (solid ankle cushion heel).

During heel strike, the heel decreases impact on the limb and allows thepatient to easily bring the forefoot to a floor. A cushioned heel mayallow a gradually increasing load to the posterior strut as the tibiamoves forward, while the plantarflexed foot position increases thedegree of deflection and amount of energy storage from midstance throughterminal stance. Energy storage and return is evident during agilitydrills, running, and sprinting activities, which are primarily performedwhile up on the forefoot. A distal third of the plantar surface may havea dorsiflexion radius design that maintains solid metatarsal contact tothe ground for increased proprioception and control.

In a specific embodiment, the alignment of the orthosis can be adjustedon average up to about 7° of dorsiflexion, plantarflexion, and externalor internal rotation and about 5° of inversion or eversion.

E. Versions of the Exoskeletal Orthosis

In a specific embodiment, the orthosis may comprise cushioned foamattached to a proximal sole on a bottom portion the anklesection/footplate. The cushioned foam may be an entirely different andseparate component from the orthosis, as the foam may requirefabrication by a specially trained orthotist (preferablyprosthetist-orthotist) and orthotic technician. Thickness and density ofthe foam are specific to a patient's relative ankle position, injury,weight, height, and activity level.

In embodiments, the orthosis may be made from modular components orfixed components. A modular version may be used during initial fittingsand may be modified as patients progress during their rehabilitation,for example, progressing from a softer strut to a stiffer strut as theybecome stronger. The modular version may also include an externalfixator (e.g., fastener and mounting plates).

In a specific embodiment, a modular version may comprise a flat bar(e.g., TRULIFE Littig) posterior strut. The posteriorly mounted ‘runplate’ may be utilized in a posterior-mounted running prosthesis. Thealignment of the ankle section/footplate may also be modifiable. Theangle of the footplate may be adjusted within 6 different planes,similar to adjustments for a prosthesis, in relation to a patient's footand leg. In specific embodiments, the modular version may have aposterior strut that is attached to the proximal cuff proximally via anÖSSUR® posterior mounted run plate with two bolts, plus a second ÖSSUR®posterior mounted run plate with two bolts at the distal end of theposterior strut (FIGS. 1-2).

In a specific embodiment, a fixed version may comprise a dual bar strut(e.g., MEDI CLEVER BONE™) for an overall lighter weight of the brace,use for higher loading and impact activities (greater durability), andthe capacity for twisting motions of the lower leg. The fixed versionallows for use inside boots and tighter clothing about the legs. Thedual bar strut may be permanently attached (bonded) to the proximal cuffproximally and the foot/ankle component distally (as shown in FIG. 3).The fixed version may allow an inherent torsional component andaccommodates twisting motions more than the modular version. The fixedversion has subjectively shown an increased energy return and improvedhigh intensity performance associated with its springlike effect, perverbal accounts from patients. However, it may be possible to use a dualposterior strut configuration in a modular version.

F. Partial Foot Embodiment

With reference now to FIGS. 6a-b , a partial foot orthosis 200 may beapplied to individuals with amputation of part of the foot. The partialfoot exoskeletal orthosis 200 may have a similar construction to theorthosis 100 discussed above. The partial foot orthosis 200 has acircumferential configuration of the footplate 205 (extending around thearea of the foot that was amputated).

With reference now to FIG. 7, another embodiment of the orthosis 100 isshown in which at least one of the proximal cuff 110 or anklesection/footplate 140 comprise a laminate material.

G. Knee Ankle Foot Orthosis

With reference now to FIGS. 8-9, an embodiment of the present inventiondirected to a knee ankle foot orthosis 300 is shown. In one or moreembodiments, the knee ankle foot orthosis 300 may comprise a modularremovable fabricated version that allows a patient to attach or detach aknee orthosis section 305 to an ankle foot orthosis (AFO) section 310depending on desired activity and limb stability needs.

In one or more embodiments, the knee ankle orthosis 300 may comprise afixed version comprising a connector or hinge 315 (e.g., Tm5 or originalTOWNSEND stainless steel knee hinge) in which the upper knee orthosissection 305 is connected or fused to the lower ankle foot orthosissection 310.

The knee ankle foot orthosis may be either modular or fixed, and may beused for varying weaknesses, nerve injuries, ligamnentous injuries,proximal knee or femoral fx's histories to allow a patient to walk, run,or perform some level of high impact activity with greater function andincreased safety.

Knee ankle foot orthosis versions, both modular and fixed, may also beused for dynamic exoskeletal orthosis cases deploying and participatingin fast rope helicopter jumps, static line parachuting, or standardparachuting maneuvers to prevent potential knee injuries while using thedynamic exoskeletal orthosis for prior injury of the ankle, nerve, andthe like.

H. Single Strut Embodiment

With reference now to FIGS. 10-11, an exoskeletal orthosis 100 maycomprise a proximal cuff 110, an ankle section/footplate 140, and asingle posterior strut 130 (e.g., MEDI CLEVER STRUT) connecting a rearof the proximal cuff to a rear of the ankle section/footplate. Inspecific embodiments a top of the single posterior strut may beincorporated into a rear of proximal cuff 110 and a bottom of the singleposterior strut may be incorporated into a rear of the anklesection/footplate 140. As shown in FIGS. 10-11, the proximal cuff 110may have at least one strap 120 that at least partially surround twoparts of the proximal cuff that are joined by hinge 115 (see also FIG.2). The at least one strap 120 may have a buckle, clasp, VELCRO® brandhook and loop fastener, snap-fit, or other means for adjusting the atleast one strap.

In specific embodiments, the single posterior strut 130 may have atubular or cylindrical shape. The length the single posterior strut maybe chosen based on the needs of a patient or user. A longer strut mayconfer addition flexibility, while a shorter strut may give addedsupport to the user's leg depending on the particular injury. Inspecific embodiments, the single strut may have a length of betweenabout 5 inches to 13 inches (15.2 cm to 33 cm), for example 7 inches to11 inches (17.8 cm to 28 cm). Likewise, the diameter of the singleposterior strut may be based on at least one of a weight of the user,activity level of the user, or the nature of the user's injury. Inspecific embodiments, the single posterior strut 130 may comprise atleast one of a carbon material, reinforced carbon fiber composition, orresin material.

The single posterior strut embodiment may allow for increasedflexibility, for example during walking, and also allows for increasedtwisting ability, for example during activities requiring rotation(e.g., golf). The single posterior strut embodiment is particularlyadaptable to daily use and wear, but not for an extended period ofrunning or strenuous activity. In contrast, a dual strut configuration(e.g., FIG. 3) may be used for strenuous activities.

I. Modified Knee Ankle Foot Orthosis

With reference now to FIGS. 12-15, another embodiment of a knee anklefoot orthosis 300 is shown comprising an upper knee orthosis section 305or cuff connected to an ankle foot orthosis section 310 (proximal cuff110, at least one posterior strut 130, and ankle section/footplate 140).In a specific embodiment, the at least one posterior strut may comprisedual posterior struts connecting a rear of the proximal cuff to a rearof the ankle section/footplate.

In specific embodiments, a modified knee ankle foot orthosis 300 maycomprise a modular removable version that allows a patient to attach ordetach the knee orthosis section 305 to the ankle foot orthosis (AFO)section 310 depending on desired activity and limb stability needs.

A fixed version of the knee ankle orthosis may also be provided in whichthe upper knee orthosis section 305 and ankle foot orthosis section 310may be monolithic. The fixed version may be appropriate, for example,for a user who has a spinal cord injury of a permanent knee nerveinjury. In one or more embodiments, the fixed version of the knee anklefoot orthosis 300 may comprise a connector or hinge 315 (e.g., Tm5 ororiginal TOWNSEND knee hinges) with an upper knee orthosis section 305or cuff fused to a lower monolithic exoskeletal ankle foot orthosissection 310.

The upper knee orthosis section 305 may comprise at least one strap 320(for example, two straps as shown in FIG. 13) to at least partiallysurround both the upper knee ankle orthosis section 305 and a rear auser's leg above the knee, thereby helping affix the upper knee orthosissection 305 to the user. The at least one strap 320 may have a buckle,clasp, VELCRO® brand hook and loop fastener, snap-fit, or other meansfor adjusting the at least one strap.

In FIGS. 12-15, the upper knee orthosis section 305 comprises at leastone stretchable band 325 affixed on each side, for example, twostretchable bands 325 affixed on each side. The at least one stretchableband 325 may be fixed at a proximal attachment or a distal attachment onthe upper knee orthosis section 305. For example, there may be onestretchable band 325 affixed proximally at or near the posterior of theknee orthosis section between lower and upper straps 320 and anotherstretchable band 325 affixed distally at or near a side of the kneeorthosis section on a lower strap (see e.g., FIG. 13).

In specific embodiments, the at least one stretchable band 325 maycomprise a rubber material, an elastic material, or a bungee cordmaterial. In a specific embodiment, the at least one stretchable bandmay comprise an elastic band adapted from a PHYSIONETICS® VP2 terminaldevice.

The at least one stretchable band 325 may be attached to the knee ankleorthosis section 305 by an appropriate means including, but not limitedto, a bolt, rivet, screw, snap-fit, or pivoting clasp. In a specificembodiment, a pivoting clasp may move or pivot when a user's knee moves.

When in use, the at least one stretchable band 325 from the upper kneeorthosis section 305 may be manually connected to a correspondingfastener or fixing means 330 on the proximal cuff 110 of ankle footorthosis section 310 (FIGS. 13-15). The corresponding fastener or fixingmeans 330 may be located at or near a side rear of the proximal cuff.The fastener or fixing means 330 may be any appropriate device and mayinclude, but is not limited to, a bolt, rivet, screw, clasp, and thelike. The placement of the fastener or fixing means 330 may help inproviding the level of hamstring assist that is required for a patientor user.

A manual connection allows a user or patient to use the at least onestretchable band 325 or to decide not to use the at least onestretchable band 325, depending on the activity, environment, and/orinjury. Thus, for example, if there are two stretchable bands on eachside of the knee orthosis section 305, a patient may manually connectjust one pair of stretchable bands to the ankle foot orthosis section310 (e.g., FIG. 13).

This embodiment of the knee ankle foot orthosis acts like an artificialhamstring and, in particular, may be helpful to individuals withhamstring injuries or sciatic nerve problems. This version of the kneeankle foot orthosis also allows for backward movement, thereby allowingfor a controlled normal type of running.

J. Alignable and Non-Alignable Versions of Orthosis

With reference now to FIGS. 16a -17, in specific embodiments, theexoskeletal orthosis may have an alignable (FIGS. 16a-16b ) or anon-alignable (FIG. 17) configuration. Both configurations may be fixedor modular.

The alignable or non-alignable exoskeletal orthosis comprise a proximalcuff; an ankle section/footplate; and at least one posterior strutconnecting a rear of the proximal cuff to a rear of the anklesection/footplate. In the alignable configuration, the at least oneposterior strut (e.g., dual posterior struts) is connected to at leastone of the ankle/footplate or the posterior cuff via a bolt mechanism400, as shown in FIGS. 16a -16 .

In specific embodiments, the bolt mechanism 400 may comprise at leastone threaded bolt 405, a washer 410, and two opposing discs 415, 420.Each of the two opposing discs 415, 420 may have reciprocal curvedsurfaces (as shown in FIG. 16b ) for receiving a posterior strut.

Between a bottom opposing disc 420 and a surface of the ankle/footplate140, at least one angled wedge 425 may be placed to allow foranteroposterior or lengthwise alignment changes or mediolateral orcrosswise alignment changes. The angled wedge 425 may have, for example,about 1-8° rise or incline. A threaded laminate plate 430 for tighteningthe bolt mechanism may be placed below a surface of the ankle/footplate.In specific embodiments, the laminate plate 430 may have a thickness of0.2 inches to 0.5 inches (5 mm to 12.7 mm), for example, 0.25 inches to0.4 inches (6 mm to 10 mm)

FIG. 17 shows a non-alignable configuration in which the at least oneposterior strut 130 (e.g., a dual strut configuration) is fixed onto anankle/footplate 140 and a proximal cuff 110, for example via upper andlower mounting plates 440 a, 440 b respectively. The upper and lowermounting plates 440 a, 440 b each have moldable flaps or wings 450,extending from the sides thereof. The moldable flaps or wings 450 maycomprise a moldable metal, such as a wire cage or moldable metal band.The moldable flaps or wings 450 allow for contouring and securing themounting plates and at least one posterior strut to the proximal cuff110 and/or ankle/footplate 140.

K. Uses

The exoskeletal orthosis is a viable alternative to amputation despitesevere impairment of the leg. In addition, the exoskeletal orthosis mayallow at least one of: 1) a more normal walking or running pattern forthose with severe injury to the leg, ankle, and/or foot that results indecreased ankle range of motion or increased pain; 2) those with anisolated peroneal neuropathy to run; 3) those with tibial neuropathy towalk and run; or 4) increased agility (stepping forward, backward,side-to-side) despite stated physical impairments. The orthosis alsopromotes use and subsequent strengthening of the quadriceps muscleduring everyday activities. The orthosis may also be used for spinalcord injuries in which there is weakness at the ankle and at least 4 outof 5 strength in the knee.

The exoskeletal orthosis of the present invention may be modified toallow safer and more normalized gait pattern during the earlypostoperative period after leg/foot/ankle surgery instead of the CAMboot (a ‘walking boot’) The orthosis may also be used as a pediatricdevice for those with cerebral palsy who have ankle plantarftexionweakness associated with Achilles lengthening procedures and hamstringweakness.

Although the present invention has been described in terms of particularexemplary and alternative embodiments, it is not limited to thoseembodiments. Alternative embodiments, examples, and modifications whichwould still be encompassed by the invention may be made by those skilledin the art, particularly in light of the foregoing teachings.

Those skilled in the art will appreciate that various adaptations andmodifications of the exemplary and alternative embodiments describedabove can be configured without departing from the scope and spirit ofthe invention. Therefore, it is to be understood that, within the scopeof the appended claims, the invention may be practiced other than asspecifically described herein.

What is claimed is:
 1. A knee ankle foot orthosis, comprising: aproximal cuff; an ankle section/footplate; dual posterior struts, eachof the dual posterior struts comprising a straight bar, wherein a firstend of each straight bar is attached to a rear of the proximal cuff andan opposing second end of each straight bar is attached to a rear of theankle section/footplate to connect the proximal cuff to the anklesection/footplate such that the dual posterior struts are parallel toone another and extend from the rear of the proximal cuff straight tothe rear of the ankle section/footplate; and an upper knee orthosissection connected to the proximal cuff and configured to be positionedabove a knee, the upper knee orthosis section having two stretchablebands affixed on a first side of the upper knee orthosis section and twostretchable bands affixed on a second side of the upper knee orthosissection.
 2. The orthosis according to claim 1, wherein the twostretchable bands on the first side and the two stretchable bands on thesecond side are affixed to the upper knee orthosis section via acorresponding pivoting clasp.
 3. The orthosis according to claim 2,wherein each pivoting clasp is affixed to the upper knee orthosis andmovable about a point of attachment to the upper knee orthosis.
 4. Theorthosis according to claim 1, wherein the upper knee orthosis sectionis connected to said proximal cuff via a hinge.
 5. The orthosisaccording to claim 1, wherein each of the two stretchable bands on thefirst side of the upper knee orthosis section and each of the twostretchable bands on the second sides of the upper knee orthosis sectioninclude rubber material, an elastic material, or a bungee cord material.6. The orthosis according to claim 1, wherein the proximal cuff includesa fastener for manual connection of the two stretchable bands on thefirst side of the upper knee orthosis section to the proximal cuff and afastener for manual connection of the two stretchable bands on thesecond side of the upper knee orthosis section to the proximal cuff. 7.The orthosis according to claim 1, wherein the two stretchable bandsaffixed on the first side of the upper knee orthosis section include afirst band affixed proximally at or near a posterior of the upper kneeorthosis section, and a second band affixed distally at or near a sideof the upper knee orthosis section; and the two stretchable bandsaffixed on the second side of the upper knee orthosis section include afirst band affixed proximally at or near a posterior of the upper kneeorthosis section, and a second band affixed distally at or near a sideof the upper knee orthosis section.
 8. The orthosis according to claim1, wherein each of the dual posterior struts is permanently bonded tothe proximal cuff and to the ankle section/footplate.
 9. An exoskeletalorthosis, comprising: an upper knee orthosis having an upper knee cuffconfigured to be positioned above a user's knee and having at least onestrap to surround a rear of a user's thigh, two stretchable bandsaffixed on a first side of the upper knee cuff, and two stretchablebands affixed on an opposing second side of the upper knee cuff, whereinone stretchable band on the first side is affixed proximally at or neara posterior of the upper knee cuff, and another stretchable band on thefirst side is affixed distally at or near a side of the upper knee cuffand one stretchable band on the second side is affixed proximally at ornear a posterior of the upper knee cuff, and another stretchable band onthe second side is affixed distally at or near a side of the upper kneecuff; and a knee ankle foot orthosis having an ankle section/footplate,a proximal cuff, at least one posterior strut connecting a rear of theankle section/footplate to a rear of the proximal cuff, and a fastenerat or near a side on the rear of the proximal cuff for manual connectionof the two stretchable bands on the first side of the upper knee cuff tothe proximal cuff and a fastener at or near a side on the rear of theproximal cuff for manual connection of the two stretchable bands on thesecond side of the upper knee cuff to the proximal cuff.
 10. Theexoskeletal orthosis according to claim 9 further comprising: a firstfastener at or near a side on a rear of a first side of the proximalcuff for manual connection of the two stretchable bands on the firstside of the upper knee cuff to the first side of the proximal cuff; anda second fastener at or near a side on a rear of a second side of theproximal cuff for manual connection of the two stretchable bands on thesecond side of the upper knee cuff to the second side of the proximalcuff.